REGISTRY for the Use of a Software for Automatic Detection of the Evolution of Aneurysmal Volume and Graft Migration After EVAR (EndoVascular Aneurysm Repair)

Aneurysm Aortic Clinical Trial

— AI-EVAR-FOLLOW  

Official title:

REGISTRY for the Use of a Software for Automatic Detection of the Evolution of Aneurysmal Volume and Graft Migration After EVAR (EndoVascular Aneurysm Repair)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05964348
• Other study ID #: CHUBX 2022/66
• Status: Withdrawn
• Start date: April 5, 2023
• Est. completion date: January 31, 2024

Study information

• Verified date: July 2023
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The objective of this registry is to find and validate a correlation between morphological indicators such as volume sac evolution, graft migration or length between anatomical landmarks with aneurysm rupture risk or complications such as endoleaks requiring re-intervention… Secondary objectives are the validation of the reproducibility and accuracy of a dedicated fully automated software enabling Abdominal Aortic Aneurysm (AAA) segmentation to measure AAA diameter, volume evolution and growth over time, proximal and distal sealing zones analyze as well as device migration and integrity after EVAR on computed tomography angiography (CTA). This validation is in comparison with semi-automated analyse controlled by physician.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 31, 2024
• Est. primary completion date: August 31, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female =18 years of age
• Infra-renal Abdominal Aortic Aneurysm (AAA) treated with EVAR
• =50mm
• or =5mm increase in 6 months
• or surviving Ruptured AAA
• legal capacity to make own decisions, informed of the nature of the registry, has signed non opposition form available for set-up and proper implementation of follow-up visits throughout the duration of the registry

Exclusion Criteria:

• Advancing Alzheimer's disease or socially dependent patient
• Opposition to the use of their data for this research
• Life expectancy supposed to be inferior to 2 years Pregnant female

Related Conditions & MeSH terms

• Aneurysm
• Aneurysm Aortic
• Aortic Aneurysm

Intervention

Procedure:
• CT-Scan
semi-automated analyse by anatomical landmarks with a dedicated fully automated software

Locations

Country	Name	City	State
France	Service de Chirurgie Vasculaire, Hôpital Pellegrin-tripode, CHU de Bordeaux	Bordeaux cedex

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Bordeaux	Nurea

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Collection of the different events and complications of the aneurysm post EVAR	Collection of the different events and complication occurred after the EVAR (post-operative (up to one month), 3, 6 and 12 months). The collection will be use to correlate with the measurement of the morphological indicators collected at the different time frame of the study	Month 1
Primary	Collection of the different events and complications of the aneurysm post EVAR	Collection of the different events and complication occurred after the EVAR (post-operative (up to one month), 3, 6 and 12 months). The collection will be use to correlate with the measurement of the morphological indicators collected at the different time frame of the study	Month 3
Primary	Collection of the different events and complications of the aneurysm post EVAR	Collection of the different events and complication occurred after the EVAR (post-operative (up to one month), 3, 6 and 12 months). The collection will be use to correlate with the measurement of the morphological indicators collected at the different time frame of the study	Month 6
Primary	Collection of the different events and complications of the aneurysm post EVAR	Collection of the different events and complication occurred after the EVAR (post-operative (up to one month), 3, 6 and 12 months). The collection will be use to correlate with the measurement of the morphological indicators collected at the different time frame of the study	Month 12
Primary	Measurement of aneurysm sac volume evolution	Measurement of the aneurysm sac volume in cc on the CT scans available	Month 1
Primary	Measurement of aneurysm sac volume evolution	Measurement of the aneurysm sac volume in cc on the CT scans available	Month 3
Primary	Measurement of aneurysm sac volume evolution	Measurement of the aneurysm sac volume in cc on the CT scans available	Month 6
Primary	Measurement of aneurysm sac volume evolution	Measurement of the aneurysm sac volume in cc on the CT scans available	Month 12
Primary	Measurement of morphological neck characteristics	Measurement of the morphological neck characteristics in mm on the CT scans available	Month 6 before intervention
Primary	Measurement of morphological neck characteristics	Measurement of the morphological neck characteristics in mm on the CT scans available	Month 1
Primary	Measurement of morphological neck characteristics	Measurement of the morphological neck characteristics in mm on the CT scans available	Month 3
Primary	Measurement of morphological neck characteristics	Measurement of the morphological neck characteristics in mm on the CT scans available	Month 6
Primary	Measurement of morphological neck characteristics	Measurement of the morphological neck characteristics in mm on the CT scans available	Month 12
Primary	Measurement of graft migration	Measurement of the graft migration if existing on the CT scans available	6 months before intervention
Primary	Measurement of graft migration	Measurement of the graft migration if existing on the CT scans available	Month 1
Primary	Measurement of graft migration	Measurement of the graft migration if existing on the CT scans available	Month 3
Primary	Measurement of graft migration	Measurement of the graft migration if existing on the CT scans available	Month 6
Primary	Measurement of graft migration	Measurement of the graft migration if existing on the CT scans available	Month 12
Primary	Measurement of length between anatomical points evolution	Measurement of the length between anatomical points evolution of the aneurysm in mm on the CT scans available.	6 months before intervention
Primary	Measurement of length between anatomical points evolution	Measurement of the length between anatomical points evolution of the aneurysm in mm on the CT scans available.	Month 1
Primary	Measurement of length between anatomical points evolution	Measurement of the length between anatomical points evolution of the aneurysm in mm on the CT scans available.	Month 3
Primary	Measurement of length between anatomical points evolution	Measurement of the length between anatomical points evolution of the aneurysm in mm on the CT scans available.	Month 6
Primary	Measurement of length between anatomical points evolution	Measurement of the length between anatomical points evolution of the aneurysm in mm on the CT scans available.	Month 12
Secondary	Repeatability between one senior and one junior surgeon (inter observer variability) for the Semi-automatic segmentation	Descriptive analysis of the semi-automatic segmentation for the junior and senior surgeon by overlaps metric analysis	Month
Secondary	Repeatability between one senior and one junior surgeon (inter observer variability) for the Semi-automatic segmentation	Descriptive analysis of the semi-automatic segmentation for the junior and senior surgeon by overlaps metric analysis	6 months before intervention
Secondary	Repeatability between one senior and one junior surgeon (inter observer variability) for the Semi-automatic segmentation	Descriptive analysis of the semi-automatic segmentation for the junior and senior surgeon by overlaps metric analysis	Month 1
Secondary	Repeatability between one senior and one junior surgeon (inter observer variability) for the Semi-automatic segmentation	Descriptive analysis of the semi-automatic segmentation for the junior and senior surgeon by overlaps metric analysis	Month 3
Secondary	Repeatability between one senior and one junior surgeon (inter observer variability) for the Semi-automatic segmentation	Descriptive analysis of the semi-automatic segmentation for the junior and senior surgeon by overlaps metric analysis	Month 6
Secondary	Repeatability between one senior and one junior surgeon (inter observer variability) for the Semi-automatic segmentation	Descriptive analysis of the semi-automatic segmentation for the junior and senior surgeon by overlaps metric analysis	Month 12
Secondary	Repeatability between measures (intra observer variability)	Descriptive analysis of the different measurements by overlaps metric analysis	6 months before intervention
Secondary	Repeatability between measures (intra observer variability)	Descriptive analysis of the different measurements by overlaps metric analysis	Month 1
Secondary	Repeatability between measures (intra observer variability)	Descriptive analysis of the different measurements by overlaps metric analysis	Month 3
Secondary	Repeatability between measures (intra observer variability)	Descriptive analysis of the different measurements by overlaps metric analysis	Month 6
Secondary	Repeatability between measures (intra observer variability)	Descriptive analysis of the different measurements by overlaps metric analysis	Month 12
Secondary	Average time for segmentation (sec)	The time for segmentation by junior/senior surgeon and software is recorded	6 months before intervention
Secondary	Average time for segmentation (sec)	The time for segmentation by junior/senior surgeon and software is recorded	Month 1
Secondary	Average time for segmentation (sec)	The time for segmentation by junior/senior surgeon and software is recorded	Month 3
Secondary	Average time for segmentation (sec)	The time for segmentation by junior/senior surgeon and software is recorded	Month 6
Secondary	Average time for segmentation (sec)	The time for segmentation by junior/senior surgeon and software is recorded	Month 12
Secondary	Average time for segmentation in comparison with semi-automated segmentation	Description of the average time between the different techniques.	6 months before intervention
Secondary	Average time for segmentation in comparison with semi-automated segmentation	Description of the average time between the different techniques.	Month 1
Secondary	Average time for segmentation in comparison with semi-automated segmentation	Description of the average time between the different techniques.	Month 3
Secondary	Average time for segmentation in comparison with semi-automated segmentation	Description of the average time between the different techniques.	Month 6
Secondary	Average time for segmentation in comparison with semi-automated segmentation	Description of the average time between the different techniques.	Month 12
Secondary	Total Volume measurement of AAA	Description of the volume measurement of the AAA with the following items: Volume circulating; Intraluminal thrombus volume; Calcification volume	6 months before intervention
Secondary	Total Volume measurement of AAA	Description of the volume measurement of the AAA with the following items: Volume circulating; Intraluminal thrombus volume; Calcification volume	Month 1
Secondary	Total Volume measurement of AAA	Description of the volume measurement of the AAA with the following items: Volume circulating; Intraluminal thrombus volume; Calcification volume	Month 3
Secondary	Total Volume measurement of AAA	Description of the volume measurement of the AAA with the following items: Volume circulating; Intraluminal thrombus volume; Calcification volume	Month 6
Secondary	Total Volume measurement of AAA	Description of the volume measurement of the AAA with the following items: Volume circulating; Intraluminal thrombus volume; Calcification volume	Month 12